As need for more aggressive drug development that still ensures the safety of the subjects and the drug itself becomes more and more important, the challenges of those individuals responsible for the Phase I activities increase exponentially. To not meet these challenges has consequences.

The lines of distinction between the classical phases in the drug development are becoming more and more blurred, and the challenges facing the Sponsor, the Principal Investigator, and the sites are becoming increasingly important. No longer is the First-in-Man study only done on normal healthy volunteers or are protocols fixed lines in the sand that are not changeable until the study is completed.

No longer is the New Chemical Entity (NCE) a simple chemical with almost predictable effects and we no longer see Phase I studies conducted only in confined Clinical Pharmacology Units. All of these challenges make recruiting more challenging and Monitoring equally so.

The answer is to identify the challenges and keep up with the changing environment in the development of these NCE’s in ever more complex and serious diseases so that the DRA’s find nothing to shut you down for. The focus of this 90-minute webinar is how to overcome the challenges in Phase I and FIM studies.

• What are the factors in choosing a defendable first dose of a NCE
• How to Set up of a site that is prepared for First-in-man studies
• How to develop an effective / efficient Phase I Program to be audit clear
• How to recruit Study Participants in this new age of Social Media
• How to not miss and accurately assess important Adverse Events
• How a well written Protocol prevents errors and warning letters
• How to not miss “safety Assessments” when you really do not know what to look for

This Webinar will provide invaluable assistance to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects.

Those benefiting the most would be:

• Holders of the IND for new products
• Principal Investigators and sub investigators
• Clinical Research Scientists (PKs, Biostatisticians, ...)
• Safety Nurses
• Clinical Research Associates (CRAs) and Coordinators (CRCs)
• Recruiting staff
• QA / QC auditors and staff
• Study Monitors
• Clinical Research Data managers

Charles H. Pierce, MD, PhD, FCP, CPI is a consultant in the Clinical Research / Drug-Device Development arena specializing in bringing the message (via Webinars, lectures and seminars) of Risk Management through knowledge of GCP Regulations and Investigator Responsibility to the entire investigative team.

He has been in the Clinical Research Industry for 22+ years. He has been involved in Investigator and staff GCP training, and medical monitoring in both drug and device studies.

Registration - Session Only: $299.00

CD Recording Only: $499.00